Plan for the commercial launch of your device in the European Economic Area (EEA). Ensure that all marketing and promotional materials reflect the CE mark and comply with labeling requirements.

Quality management systems – Requirements for regulatory purposes, ensuring consistent design, production, and distribution of medical devices.

Detailed description of the medical device, including its intended use, design features, and specifications (e.g., dimensions, materials, components).

Device Classification: The classification of your medical device (Class I, IIa, IIb, III) dictates the complexity of the certification process. Higher-risk classes (IIa, IIb, III) typically require more extensive conformity assessment processes, potentially leading to longer processing times.

Determine the correct classification of your medical device (Class I, IIa, IIb, III) based on its intended use and potential risks. Different classes require varying levels of conformity assessment and involvement of Notified Bodies.

Determine the classification of your medical device (Class I, IIa, IIb, III) based on its intended use and potential risks. This classification dictates the conformity assessment route.

Device Description: Detailed description of the device, including its intended use, specifications, and components.

Determine the correct classification of your medical device (Class I, IIa, IIb, III) based on its intended use and potential risks. This classification dictates the conformity assessment route.